Download the all-new HCP Life Science Packaging Materials Playbook and find out how to consistently select the optimal packaging style and material for your pharma, medicinal devices. Learn More »
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending Web sites.
The announcement takes place during the 5th annual International Internet Week of Action (IIWA), a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. This year's effort—Operation Pangea V—was conducted between Sept. 25 and Oct. 2 and resulted in the shutdown of more than 18,000 illegal pharmacy Web sites and the seizure of about $10.5 million worth of pharmaceuticals worldwide.
The goal of this annual effort, which involved law enforcement, customs, and regulatory authorities from 100 countries, is to identify producers and distributors of illegal pharmaceutical products and medical devices and remove these products from the supply chain.
“Consumers in the United States and around the world face a real threat from Internet pharmacies that illegally sell potentially substandard, counterfeit, adulterated, or otherwise unsafe medicines,” says FDA Commissioner Margaret A. Hamburg, M.D. “This week's efforts show that strong international enforcement efforts are required to combat this global public health problem. The FDA is committed to joining forces to protect consumers from the risks these Web sites present.”
Last week, the FDA reinforced its online efforts with the launch of a national campaign to educate Americans about the risks of buying prescription medications over the Internet. BeSafeRx—Know Your Online Pharmacy seeks to raise public awareness about the health risks of using fraudulent Internet pharmacies and what consumers can do to protect themselves.
During Operation Pangea V, the FDA targeted Web sites selling unapproved and potentially dangerous medicines. In many cases, the medicines can be detrimental to public health because they contain active ingredients that are approved by FDA for use only under the supervision of a licensed health care practitioner or active ingredients that were previously withdrawn from U.S. market due to safety issues.
Among the illegal medicines identified through the operation were:
• Domperidone: This medicine was removed from the U.S. market in 1998 because it may cause serious adverse effects, including irregular heartbeat, stopping of the heart, or sudden death. These dangers could convey to the nursing baby of breastfeeding women, who may be using domperidone to try increase milk production (which is not an approved use).
• Isotretinoin (previously marketed as Accutane in the U.S.): This medicine is used to treat severe nodular acne and carries significant potential risks, including severe birth defects if pregnancy occurs while using this medicine. To minimize potential risks to consumers, FDA-approved isotretinoin capsules are only available through restricted distribution in the U.S.
• Tamiflu (oseltamivir phosphate): This medicine, which is used to treat the flu, is often sold online as “generic Tamiflu.” However, there is no FDA-approved generic version of Tamiflu. Previous FDA tests found that fraudulent versions of “generic Tamiflu” contained the wrong active ingredient, which would not be effective in treating flu. In these cases, the wrong active ingredient was similar to penicillin and may cause a severe allergic reaction, including a sudden, potentially life-threatening reaction called anaphylaxis, in consumers allergic to penicillin products.
• Viagra (sildenafil citrate): This medicine is used to treat erectile dysfunction. Due to its vasodilation effects, sildenafil citrate should not be used by consumers with certain heart conditions. Consumers taking this medicine without the supervision of a health care professional may not learn about potential drug interactions, such as increased blood pressure lowering effects of organic nitrates when taken with sildenafil citrate.
The FDA sent Warning Letters to the operators of more than 4,100 identified Web sites. As a follow up, the agency sent notices to Registries, Internet Service Providers (ISPs), and domain Name Registrars (DNRs) informing them that these Web sites were selling products in violation of U.S. law. The FDA is working with its foreign counterparts to address the remaining Web sites that continue to offer unapproved or misbranded prescription medicines to U.S. consumers.
“Internet pharmacies that illegally sell unapproved, counterfeit, or potentially adulterated or substandard drugs are an inherently international crime problem,” says John Roth, director of the FDA's Office of Criminal Investigation. “The FDA is pleased to work with Interpol, the international police agency, to fight this problem. Because these criminals do not respect international borders, the international coordinated law enforcement response represented by Operation Pangea demonstrates that international cooperation is the best way to protect the American public from the risk of unsafe drugs.”
The FDA coordinated the efforts of this year's Operation Pangea V, including screening all drug products received through the international mail facilities during the IIWA. Preliminary findings showed that certain products from abroad, such as antibiotics, antidepressants, and other drugs to treat high cholesterol, diabetes, and high blood pressure, were on the way to U.S. consumers. Many of those products can pose health risks if taken without the supervision of a health care practitioner or if the products have been removed from the market for safety reasons.
The FDA encourages consumers to report suspected criminal activity at www.fda.gov/oci.
The IIWA is a collaboration between FDA, Interpol, the World Customs Organization, Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the Medicines and Healthcare products Regulatory Agency of the United Kingdom, the Irish Medicines Board, the London Metropolitan Police, the U.S. Department of Homeland Security, the Center for Safe Internet Pharmacies, and national health and law enforcement agencies from 100 participating countries.
MHRA plays vital role
The following details are sourced from an online press release from the U.K.-based Medicines and Healthcare products Regulatory Agency (MHRA):
More than £6.5 million worth of counterfeit and unlicensed medicines has been seized across the globe as part of a week-long international crackdown on the illicit Internet trade in pharmaceuticals.
Internationally, preliminary results show that more than 133,000 packages were inspected by regulators and customs officials, resulting in the seizure of more than 3.7 million doses of unlicensed and counterfeit pills.
Coordinated by Interpol and carried out with the assistance of police, customs, and national medicines regulators, the operation targeted the four main elements misused in the illegal Web site trade—the drugs supplier, internet infrastructure, the electronic payment system, and the mail delivery service.
In the U.K., enforcement officers from MHRA, with assistance from local police, arrested two people and raided 10 addresses in connection with the illegal Internet supply of medicines. Eight computers were seized as well as financial correspondence.
In conjunction with the Border Force, the MHRA seized more than 2.3 million doses of unlicensed medicine worth approximately £3.8 million, including 68,000 doses of counterfeit pills.
The MHRA is also working with the Metropolitan Police Service (MPS) Central eCrime Unit (PCeU) and international partners to tackle spam e-mails received by people advertising unlicensed and counterfeit medicines. These spam emails come from affiliate pharmacy networks that are run by organised crime groups. The MHRA and the PCeU have joined forces with Microsoft, MasterCard, Visa, PayPal, Interpol, Irish Medicines Board, U.S. Dept. of Homeland Security, LegitScript, the U.S. Food and Drug Administration, and FBI to tackle the Internet infrastructure that facilitates this criminality by targeting seven of the largest spam networks aiming to have the Web sites shut down and payment facility removal. This is groundbreaking work and may lead to significant inroads in tackling criminality on the Internet.
MHRA Acting Head of Enforcement, Nimo Ahmed, says: “This week we have recovered a range of medicines being supplied without prescriptions and stored in unacceptable conditions by people who are not qualified to dispense medicines.
“When you buy medicines from an unregulated source you don't know what you're getting, where it came from, or if it's safe to take. The dose could be too high or too low, or the ingredients could break down incorrectly in the body which makes the medicine ineffective.
“Illegal suppliers do not adhere to quality control or standards that are required in the licensed trade. If people could see the filthy conditions some of these medicines are being made, stored and transported in, they certainly wouldn't touch them.
“The bottom line is that there are no quick fixes when it comes to your health. Take the time to see your GP to identify the cause of your symptoms. You are far more likely to get better faster if you are on the correct course of prescribed medication.”
Working alongside the MHRA, the Metropolitan Police Service (MPS) Police Central eCrime Unit (PCeU) also took action to combat those profiting from the unlawful sale and distribution of pharmaceuticals online.
More than 384 generic top-level domains and sub domains have been suspended on the U.K. domain tree and a further 120 domain names are being shut down.
Detective Superintendent Charlie McMurdie, head of the Police Central e-Crime Unit says, "We are pleased to have contributed, with partners, to this operation. Together we have proactively prevented harm to victims by disrupting the infrastructure criminals use to illegally sell pharmaceuticals online.
"This type of crime causes significant harm to the U.K. economy, generating millions of pounds of criminal profit. The MHRA's International Internet Week of Action continues to form part of our wider remit to protect people from Internet-facilitated crime."
Border Force Senior Operations Manager—Coventry International Hub, Dave Bagnall, says, “The haul detected by our officers during this week of action makes it clear just how seriously we take the smuggling of fake and unlicensed medicines.
“Smugglers are only out to make a profit. These goods are often dangerous and the proceeds can be used to fund serious organized crime.”
The Royal Pharmaceutical Society's Neal Patel, says: “It is hugely worrying that prescription medicines are available from illicit Web sites. This is a serious patient safety issue.
“Not only is supplying Prescription Only Medicines without a prescription illegal, it means that the user has no information about the ingredients, dosage instructions, or potential side effects, so patients would not be receiving proper healthcare advice.
“We would urge the public if they wish to buy medicines online to always check that they are dealing with a genuine pharmacy.”
If someone suspects their medicine may be counterfeit, contact the MHRA's designated 24-hour anti---counterfeiting hotline on 011.020.3080.6701 or email@example.com
--This article comes from Oct. 4 press releases issued by the U.S. FDA and the U.K.'s MHRA. Photo supplied by MHRA.